Journal of Pharmaceutical Care & Health Systems
Open Access

Pre-formulation and early formulation development: Assessing risks and strategies

Global Pharma Summit

August 10-12, 2015 Philadelphia, USA

Madhusree Gokhale

Posters-Accepted Abstracts: J Pharma Care Health Sys

Abstract :

Pre-formulation and exploratory formulation development studies are critical in defining drug product strategies for first in human studies leading to commercial dosage form development. Exploratory development is a dynamic phase of development with limited API, tight timelines, limited knowledge of material properties and process scale up and the impact of dose change, formulation and physiological variables on bioavailability being unknown. Using an integrated approach to assess risks related to bio-pharmaceutics, material (form) and drug product processing is critical to design appropriate formulation strategies. Use of in vitro tools, in silico absorption modeling along with in vivo studies and high throughput screening techniques not only provide a robust design space early on but also lead to focused formulation development with shorter timelines. Through various case studies, this talk will cover tools and workflows that can be implemented in the pre-formulation and early formulation development space to assess bio-pharmaceutics, API form and phase transformations and drug product processing risks, highlighting a qbD approach to early development.